FDA Policy/General

Price Confirmation Likely Mid-February: Alexander

Senate HELP Committee chairman Lamar Alexander (R-TN) says Senate confirmation of HHS secretary-designate Tom Price may not come until mid-February, meaning that introduction of a replacement for the Affordable Care Act likely would not come until the beginning of March. Roll Call reports that Alexander made the comment during the 1/11 late-night Senate budget “vote-a-rama” that included legislation laying the groundwork for repealing the Affordable Care Act.

“We will have a courtesy hearing next week with Dr. Price in the HELP Committee,” Alexander said. “Finance will hear him soon after that and I would expect he would be confirmed at least by mid-February.” He suggested that the February recess “would be pretty good timing,” Roll Call says.

In a 1/11 news conference, President-elect Donald Trump said that a plan to replace the Affordable Care Act would come out once Price is confirmed. He said that the healthcare plan would be repealed and replaced with his administration’s plan almost simultaneously, rather than after a delay of perhaps up to four years as suggested by some House Republicans.

Alexander said that many cost-saving measures involve moving decisions out of Washington and back to the states, and thus it will be important for Congress to hear from the governors, who will be in Washington 2/19-22. “The timing’s very good,” he said. “They’ll be meeting with us here to get their opinions, and then we can start moving ahead step-by-step.”

He said the delay should not be significant and noted that the American people “don’t want a quick fix. They want us to do something that will last and that will help every American over the long term. We’re starting tonight with step one of repeal-and-replace, but we’re not going to repeal anything until we have concrete, practical alternatives in place for the American people.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome